Safety of HTX-019 (intravenous aprepitant) and fosaprepitant in healthy subjects. (5th June 2018)

• Record Type: Journal Article
• Authors: Ottoboni, Tom; Lauw, Michael; Keller, Mary Rose; Cravets, Matt; Manhard, Kimberly; Clendeninn, Neil; Quart, Barry
• Is Part Of: Future oncology. Volume 14:Number 27(2018)
• Page Start: 2849
• Page End: 2859
• Publication Date: 2018-06-05
• Subjects: antiemetics -- aprepitant -- safety; Oncology -- Periodicals; 616.99405
• DOI: 10.2217/fon-2018-0311
• Languages: English
• ISSNs: 1479-6694

Abstract

Aim: Evaluate safety of HTX-019, a novel polysorbate 80– and synthetic surfactant-free intravenous formulation of neurokinin 1 receptor antagonist aprepitant for chemotherapy-induced nausea and vomiting.Methods: Two open-label, randomized, two-way crossover studies evaluated treatment-emergent adverse events (TEAEs) in 200 healthy subjects. Subjects received HTX-019 130 mg (30-min infusion) and fosaprepitant 150 mg (20- or 30-min infusion), with ≥7-day washout between doses.Results: Less than or equal to 30 min after start of infusion, TEAEs occurred in 5 (3%) HTX-019 and 30 (15%) fosaprepitant recipients. No HTX-019 recipients had infusion-site adverse events, versus 15 (8%) fosaprepitant recipients. Treatment-related dyspnea occurred in one HTX-019 and six fosaprepitant recipients. No severe/serious TEAEs occurred; all TEAEs resolved.Conclusion: HTX-019 may provide a safer aprepitant formulation than fosaprepitant for chemotherapy-induced nausea and vomiting prevention.